Agency classClass IIOur severity:High FDA (Devices)·Z-1426-2022·Announced 2022-07-27

Sensis Vibe Combo Device Recalled for Software Communication Failure

The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential to impact patient monitoring during critical cardiac procedures. No illnesses or injuries are reported. The software defect prevents vital signs display during procedures, representing significant clinical risk without documented harm, qualifying as a risk-of-harm product without reported injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the Sensis Vibe Combo with software version VD12A, a diagnostic and administrative device used to support hemodynamic catheterizations and electrophysiology studies for cardiac and interventional radiology procedures.

The device may experience a communication disconnect during the first patient examination of the day or following extended periods of inactivity. When this occurs, vital signs data becomes unavailable, preventing clinicians from monitoring critical patient parameters during procedures.

The recall affects 13 units distributed across the United States, including Arizona, Florida, Kentucky, Michigan, Ohio, Puerto Rico, and Texas. Affected serial numbers are identified in the recall documentation provided by Siemens.

Healthcare facilities operating this device should contact Siemens Medical Solutions USA, Inc. for further information regarding this issue.

The recalled product

Product: Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Cardiac Diagnostic Equipment
Hazard: software-defect
communication-failure
vital-signs-unavailable
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

UDI-DI: 04056869010205 Serial Numbers: 123021
123055
123056
123058
122042
123004
122006
122026
122029
123047
123053
122011
121014.

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · software defect